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Hormone Therapy

Genomic Biomarker-Selected Therapy for Prostate Cancer (GUNS Trial)

Phase 2

Recruiting

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 (Appendix II) and a life expectancy of ≥ 3 years

Males ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

GUNS Trial Summary

This trial will test whether a therapy based on the genomic testing of prostate tumour tissue will improve clinical response. Participants will be treated with LHRHa plus APA for 8 weeks while genome sequence characterization is done. Those with unevaluable tissue will remain on LHRHa plus APA for 16 weeks. Those with evaluable tissue will be assigned to one of three sub-studies and randomized to a specific treatment arm. The study will evaluate response rate and outcomes after radical prostatectomy.

Who is the study for?

Men over 18 with high-risk localized prostate cancer, no prior treatments for it, and willing to undergo genetic testing. They must have a life expectancy of at least 3 years and be in good health otherwise. Men with severe diseases, allergies to study drugs, or who can't take oral meds are excluded.Check my eligibility

What is being tested?

The trial tests if targeted therapy based on genomic profiling improves response in men with prostate cancer. After initial treatment with hormone therapy plus apalutamide, participants may receive additional drugs like abiraterone acetate and prednisone, docetaxel or niraparib depending on their tumor's genetics.See study design

What are the potential side effects?

Possible side effects include hormonal changes due to LHRHa and APA, immune reactions from Atezolizumab, nerve issues from Niraparib, liver problems from Abiraterone Acetate & Prednisone combo; fatigue and allergic reactions are also possible.

GUNS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and my doctor expects me to live 3 more years or longer.

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I am a man aged 18 or older.

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My prostate cancer was confirmed without small cell features.

GUNS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete Pathologic Response (pCR)

Pathological Minimal Residual Disease (pMRD)

Secondary outcome measures

Generic Quality of Life (QoL)

Pain

Malignant neoplasm of prostate

GUNS Trial Design

6Treatment groups

Active Control

Group I: Group 1bActive Control3 Interventions

LHRHa plus apalutamide plus abiraterone acetate plus prednisone.

Group II: Group 1aActive Control1 Intervention

LHRHa plus apalutamide.

Group III: Group 2aActive Control2 Interventions

LHRHa plus abiraterone acetate plus prednisone.

Group IV: Group 2bActive Control3 Interventions

LHRHa plus abiraterone acetate plus prednisone plus docetaxel.

Group V: Group 3Active Control3 Interventions

LHRHa plus abiraterone acetate plus prednisone plus niraparib

Group VI: Group 4Active Control2 Interventions

LHRHa plus apalutamide plus atezolizumab

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,803 Total Patients Enrolled

10 Trials studying Prostate Cancer

2,824 Patients Enrolled for Prostate Cancer

Janssen Inc.Industry Sponsor

23 Previous Clinical Trials

7,766 Total Patients Enrolled

University Health Network, TorontoOTHER

1,476 Previous Clinical Trials

484,865 Total Patients Enrolled

63 Trials studying Prostate Cancer

15,085 Patients Enrolled for Prostate Cancer

Media Library

Apalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04812366 — Phase 2

Prostate Cancer Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT04812366 — Phase 2

Apalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04812366 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Group 1a for therapeutic applications?

"Our team at Power assigned Group 1a a safety rating of 2 due to the presence of Phase 2 trial data, which indicates that there is evidence backing its security but not yet any related to efficacy."

Answered by AI

Have there been other investigations involving Group 1a?

"At present, 776 trials are underway probing Group 1a. Of those active studies, 234 have advanced to Phase 3. Although the bulk of investigations for Group 1a take place in Duarte, California, there are 41228 sites conducting research on this intervention."

Answered by AI

What is the enrollment size of this research investigation?

"Affirmative. Clinical trials.gov information confirms that this research is presently searching for volunteers; it was initially posted on September 21st, 2021 and has been edited as recently as May 25th, 2022. 315 participants are being sought between two sites of study."

Answered by AI

Is there an ongoing effort to enroll participants in this research project?

"Affirmative. Clinicaltrials.gov supports the notion that this clinical trial is currently seeking participants, who are being sought from two sites and need to total 315 individuals in number. The post was originally made on September 21st 2021 with a recent update occurring on May 25th 2022."

Answered by AI